Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
Primary Purpose
Arrhythmias, Cardiac, Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
PulseOn Arrhythmia Monitor device
Sponsored by
About this trial
This is an interventional screening trial for Arrhythmias, Cardiac focused on measuring Wearable, Wrist-worn
Eligibility Criteria
Inclusion Criteria for the main study group:
- At least 65 years of age
- Self-assessed ability to use the study devices
- Ability to give informed consent
- Volunteering for the study
Inclusion criteria for the active endurance athlete group:
- Minimum of 10 years of active training of endurance sport (e.g. long distance running, skiing, cycling, triathlon…) and currently an average amount of training of at least 10 hours a week.
- Age: ≥ 50 years
- Self-assessed ability to use the study devices
- Ability to give informed consent
- Volunteering for the study
Exclusion Criteria for both groups:
- Cardiac pacemaker
- Earlier diagnosis of atrial fibrillation
- Inability to give informed consent
- Denial
Sites / Locations
- Tampere Heart HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Main study group
Endurance athlete group
Arm Description
Normal subjects of at least 65 years of age
Group consists of active endurance athletes of at least 50 years of age
Outcomes
Primary Outcome Measures
Diagnostic performance improvement with continuous optical measurement
Percentual improvement in the performance of detecting previously undiagnosed atrial fibrillation in the study population by the continuous PPG-based heartbeat interval monitoring when compared with relying only on scheduled and symptom -based ECG measurements. Cardiac rhythm assessed by a cardiologist from the ECG measurements that are made as a result of PPG-based arrhythmia notifications is compared with rhythm assessments made only from the scheduled and symptom-based ECG measurements. It is evaluated whether more subjects can be diagnosed having atrial fibrillation with the help of continuous PPG-based rhythm monitoring.
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing the adequacy of the obtained ECG data for clinical decision making.
Data recorded by the study subjects during the two-week study time is assessed by a cardiologist and subjects are classified as having: "no observed arrhythmias", "atrial fibrillation episode(s)", "other potential arrhythmia", or "unconfident assessment" (due to the quality or lack of data). The percentage of "unconfident assessment" shall be less than 20% of the subjects.
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks
The feedback from the subjects should show at least grade 3 in a scale of 1-5 for the "comfortability of using the wrist device".
Secondary Outcome Measures
Showing the benefit of the combined wrist-worn PPG and ECG solution in detecting other cardiac arrhythmias than atrial fibrillation.
The visual ECG-based rhythm annotation made by a cardiologist is compared with simultaneous PPG-algorithm alarm state. The incidence of notifications for other arrhythmias than atrial fibrilation is reported.
Evaluation of the necessity of performing scheduled ECG measurements in addition to ECG measurements triggered by PPG-based arrhythmia notifications for detecting atrial fibrillation.
Evaluation is done by comparing the atrial fibrillation detection outcome when considering only the PPG-triggered and symptom-based ECG measurements or when considering also the scheduled ECG measurements. The outcome parameter is the number of subjects that would have been left undetected if the scheduled ECG measurements were not taken.
Feedback about the usability of the evaluated solution from study subjects.
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the wrist device, understandability of the user interface, suitability of the user materials, and unobtrusiveness.
Feedback about the usability of the evaluated solution from study personnel.
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the data management service, suitability of the user materials.
Quality of the measured ECG signals
Percentage of the ECG measurements classified as inadequate quality for rhythm assessment either an ECG analysis algorithm or by a doctor.
Assessment of the subjects' adherence in using the solution.
Analysis of how well the participants will follow the study protocol and do the participants register their ECG in correlation with the wrist device notification. The outcome parameter is the percentage of scheduled and PPG-based notifications to take an ECG measurement and the variation of the percentage between the subjects.
Benefit of optical measurement for the speed of detecting atrial fibrillation
Comparison of the time to the first detection of atrial fibrillation or other arrhythmia when considering PPG-triggered ECG measurements or when considering the scheduled ECG measurements.
Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.
The automated assessment done for the 30-second ECG recordings is compared with the visual assessment to calculate the sensitivity and specificity for each rhythm category.
Full Information
NCT ID
NCT05196412
First Posted
November 18, 2021
Last Updated
June 6, 2022
Sponsor
PulseOn Oy
Collaborators
TAYS Sydänkeskus Oy, Atostek Oy
1. Study Identification
Unique Protocol Identification Number
NCT05196412
Brief Title
Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
Official Title
Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PulseOn Oy
Collaborators
TAYS Sydänkeskus Oy, Atostek Oy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates the performance pf PulseOn Arrhythmia Monitor System that includes a wrist-worn device, which combines continuous optical heartbeat interval monitoring and intermittent ECG measurement, and a data management system used by healthcare professionals for data observation, in the detection of previously undiagnosed cardiac arrhythmias, especially atrial fibrillation.
Detailed Description
The study consists of monitoring voluntary subjects with PulseOn Arrhythmia Monitoring System for the period of two weeks. The subjects are recruited mainly through newspaper advertisements. The study is executed in Tampere and Helsinki areas, Finland.
During the two week monitoring time, the subjects are instructed to wear the wrist device continuously, except when taking the device off e.g. for going to sauna or swimming, and for charging. The subjects are instructed to perform a 35-second ECG measurement (recording) in three cases:
Scheduled recording four times a day
In case of suspecting arrhythmic event, i.e. feeling symptoms
In case the wrist device instructs to perform a recording by vibrating and showing an LED light
The data collected in the study is analysed post-hoc. In the post-hoc analysis, the cardiac rhythm assessed automatically from the ECG measurements is visually confirmed by a cardiologist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Atrial Fibrillation
Keywords
Wearable, Wrist-worn
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main study group
Arm Type
Experimental
Arm Description
Normal subjects of at least 65 years of age
Arm Title
Endurance athlete group
Arm Type
Experimental
Arm Description
Group consists of active endurance athletes of at least 50 years of age
Intervention Type
Device
Intervention Name(s)
PulseOn Arrhythmia Monitor device
Intervention Description
Wearing of the wrist device for a period of two weeks
Primary Outcome Measure Information:
Title
Diagnostic performance improvement with continuous optical measurement
Description
Percentual improvement in the performance of detecting previously undiagnosed atrial fibrillation in the study population by the continuous PPG-based heartbeat interval monitoring when compared with relying only on scheduled and symptom -based ECG measurements. Cardiac rhythm assessed by a cardiologist from the ECG measurements that are made as a result of PPG-based arrhythmia notifications is compared with rhythm assessments made only from the scheduled and symptom-based ECG measurements. It is evaluated whether more subjects can be diagnosed having atrial fibrillation with the help of continuous PPG-based rhythm monitoring.
Time Frame
Duration of patient measurement, i.e. two weeks
Title
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing the adequacy of the obtained ECG data for clinical decision making.
Description
Data recorded by the study subjects during the two-week study time is assessed by a cardiologist and subjects are classified as having: "no observed arrhythmias", "atrial fibrillation episode(s)", "other potential arrhythmia", or "unconfident assessment" (due to the quality or lack of data). The percentage of "unconfident assessment" shall be less than 20% of the subjects.
Time Frame
Duration of patient measurement, i.e. two weeks
Title
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks
Description
The feedback from the subjects should show at least grade 3 in a scale of 1-5 for the "comfortability of using the wrist device".
Time Frame
Duration of patient measurement, i.e. two weeks
Secondary Outcome Measure Information:
Title
Showing the benefit of the combined wrist-worn PPG and ECG solution in detecting other cardiac arrhythmias than atrial fibrillation.
Description
The visual ECG-based rhythm annotation made by a cardiologist is compared with simultaneous PPG-algorithm alarm state. The incidence of notifications for other arrhythmias than atrial fibrilation is reported.
Time Frame
Duration of patient measurement, i.e. two weeks
Title
Evaluation of the necessity of performing scheduled ECG measurements in addition to ECG measurements triggered by PPG-based arrhythmia notifications for detecting atrial fibrillation.
Description
Evaluation is done by comparing the atrial fibrillation detection outcome when considering only the PPG-triggered and symptom-based ECG measurements or when considering also the scheduled ECG measurements. The outcome parameter is the number of subjects that would have been left undetected if the scheduled ECG measurements were not taken.
Time Frame
Duration of patient measurement, i.e. two weeks
Title
Feedback about the usability of the evaluated solution from study subjects.
Description
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the wrist device, understandability of the user interface, suitability of the user materials, and unobtrusiveness.
Time Frame
At the end of the 2-week measurement period
Title
Feedback about the usability of the evaluated solution from study personnel.
Description
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the data management service, suitability of the user materials.
Time Frame
At the end of the study i.e. the end of 2022.
Title
Quality of the measured ECG signals
Description
Percentage of the ECG measurements classified as inadequate quality for rhythm assessment either an ECG analysis algorithm or by a doctor.
Time Frame
Duration of patient measurement, i.e. two weeks
Title
Assessment of the subjects' adherence in using the solution.
Description
Analysis of how well the participants will follow the study protocol and do the participants register their ECG in correlation with the wrist device notification. The outcome parameter is the percentage of scheduled and PPG-based notifications to take an ECG measurement and the variation of the percentage between the subjects.
Time Frame
Duration of patient measurement, i.e. two weeks
Title
Benefit of optical measurement for the speed of detecting atrial fibrillation
Description
Comparison of the time to the first detection of atrial fibrillation or other arrhythmia when considering PPG-triggered ECG measurements or when considering the scheduled ECG measurements.
Time Frame
Duration of patient measurement, i.e. two weeks
Title
Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.
Description
The automated assessment done for the 30-second ECG recordings is compared with the visual assessment to calculate the sensitivity and specificity for each rhythm category.
Time Frame
Duration of patient measurement, i.e. two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for the main study group:
At least 65 years of age
Self-assessed ability to use the study devices
Ability to give informed consent
Volunteering for the study
Inclusion criteria for the active endurance athlete group:
Minimum of 10 years of active training of endurance sport (e.g. long distance running, skiing, cycling, triathlon…) and currently an average amount of training of at least 10 hours a week.
Age: ≥ 50 years
Self-assessed ability to use the study devices
Ability to give informed consent
Volunteering for the study
Exclusion Criteria for both groups:
Cardiac pacemaker
Earlier diagnosis of atrial fibrillation
Inability to give informed consent
Denial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antti Vehkaoja, DSc (tech)
Phone
+358407393181
Email
antti.vehkaoja@pulseon.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vesa Virtanen, PhD (med)
Organizational Affiliation
Heart Hospital of Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere Heart Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research coordinator at Heart Hospital
Phone
+358417306125
12. IPD Sharing Statement
Plan to Share IPD
No
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Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
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